Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

The Influence of Sarcopenia on Outcomes of Neuroplasty in Patients With Lumbar Spinal Stenosis: a Prospective Observational Study

The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcopenia; Lumbar Spinal Stenosis; Neurogenic Claudication
• Intervention / Treatment: Procedure: Neuroplasty with Racz catheter

Detailed Description

Frailty is an aging-related syndrome of physiological decline and correlated with sarcopenia. Furthermore, lumbar spinal stenosis is a common disease in the old population and a neuroplasty is widely used to treat these patients. We postulate that the sarcopenia may be associated with the outcome of neuroplasty in patients with lumbar spinal stenosis, and there is no study about this topic as far as we know.

To evaluate this association, we will use the criteria for sarcopenia which is made by Asian Working Group for Sarcopenia in 2019 in this study. We will compare the outcome of neuroplasty in patients with sarcopenia and without sarcopenia using several tools such as numeric rating scale (NRS), Oswestry Disability Index (ODI), and global perceived effect (GPE) score up to 6 months after the procedure.

• Study Type: Observational
• Enrollment (Anticipated): 79

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 79 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with lumbar spinal stenosis who is scheduled for neuroplasty in Asan medical center in Korea

Description

Inclusion Criteria:

• Presence of lumbar spinal stenosis on MRI
• 65 ≤ age <79
• Neurogenic claudication due to spinal stenosis
• Chronic pain above than 3 months despite conservative therapies
• Scheduled for neuroplasty with Racz catheter

Exclusion Criteria:

• Allergy to local anesthetics, contrast dye, or steroid
• Use of anticoagulants or antiplatelet medication
• Coagulopathy or Infection at the insertion site
• Neurological or psychiatric disorders
• Hemodynamic instability due to other underlying disorders
• Prior spine instrumentation
• Vascular claudication
• Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients with lumbar spinal stenosis; Patients with lumbar spinal stenosis will be scheduled for neuroplasty.

Procedure: Neuroplasty with Racz catheter; The patient is placed in the prone position with a pillow placed under the abdomen to correct the lumbar lordosis. After sterile preparation and draping, the epidural space via the sacral hiatus using a 16 gauge needle is accessed. Then, the Racz catheter is advanced to the site of adhesions under the fluoroscopic guidance. The target site is determined by the location of pathology on lumbar MRI, preprocedural epidurography, and clinical symptoms before the adhesiolysis. Adhesiolysis is performed through the high-volume administration of medications, which consist of a combination of a steroid, local anesthetics, hyaluronidase, and 5% hypertonic saline. As needed, the catheter remains in the epidural space for two days, with the additional injection on each of the days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in numeric rating scale (NRS) at 3 months after the procedure	Numeric rating scale (0-10) 0=no pain, 10=worst pain imaginable We are going to compare the change of NRS at 3 months after the procedure to the baseline value.	Before the procedure and 3 months after the procedure
Change in Oswestry disability index (ODI) at 3 months after the procedure	Oswestry disability index (10-60) 10: least score as possible, 60: most score as possible We are going to compare the change of ODI at 3 months after the procedure to the baseline value.	Before the procedure and 3 months after the procedure
Global percieved effect (GPE) score at 3 months after the procedure	Global percieved effect score by Likert scale (1-7) 1: Never satisfied with the procedure, 7: Very satisfied with the procedure	3 months after the procedure
Change in Medication Quantification scale (MQS) at 3 months after the procedure	Medication quantification scale is a tool to quantify medication regimen use in chronic pain populations. We are going to use Medication Quantification scale ver 3. The score starts at 0, and there is no specific maximum limit. We are going to compare the change of MQS at 3 months after the procedure to the baseline value.	Before the procedure and 3 months after the procedure
The percentage of successful responders at 3 months after the procedure	We are going to assess 4 variables above and then decide who is a successful responder or not at 3 months after the procedure. We defined the successful responders as follows; ≥ 50% or 4-point reduction from baseline leg Numeric rating scale and no increase from baseline Oswestry disability index and medication quantification scale and 4 points on the global perceived scale,; ≥ 30% or 2 points reduction from baseline numeric rating scale with any one of the following criteria: simultaneous ≥ 30% (or 10-point) reduction in Oswestry disability index from baseline, or ≥ 5 points on global perceived effects scale, or no increase from the baseline medication quantification scale. NRS, ODI, and MQS will be evaluated before the procedure and become baseline values. NRS, ODI, and MQS will be re-evaluated, and GPE score will be newly evaluated 3 months after the procedure.	3 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NRS at 1 and 6 months after the procedure	We are going to compare the change of NRS at 1 and 6 months after the procedure to the baseline value.	Before the procedure, and 1 and 6 months after the procedure
Change in ODI at 1 and 6 months after the procedure	We are going to compare the change of ODI at 1 and 6 months after the procedure to the baseline value.	Before the procedure, and 1 and 6 months after the procedure
GPE score at 1 and 6 months after the procedure	We are going to check GPE score at 1 and 6 months after the procedure.	1 and 6 months after the procedure
Change in MQS at 1 and 6 months after the procedure	We are going to compare the change of MQS at 1 and 6 months after the procedure to the baseline value.	Before the procedure, and 1 and 6 months after the procedure
The percentage of successful responders at 1 and 6 months after the procedure	We are going to evaluate successful responders at 1 and 6 months after the procedure	1 and 6 months after the procedure

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Doo-Hwan Kim, M.D., Asan Medical Center

Publications and helpful links

General Publications

• Bentov I, Kaplan SJ, Pham TN, Reed MJ. Frailty assessment: from clinical to radiological tools. Br J Anaesth. 2019 Jul;123(1):37-50. doi: 10.1016/j.bja.2019.03.034. Epub 2019 May 3.
• Racz G, Candido K, Helm S. Neuroplasty Is a Safe, Effective Procedure. Anesth Analg. 2018 Jan;126(1):363. doi: 10.1213/ANE.0000000000002546. No abstract available.
• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
• Yamada Y, Nishizawa M, Uchiyama T, Kasahara Y, Shindo M, Miyachi M, Tanaka S. Developing and Validating an Age-Independent Equation Using Multi-Frequency Bioelectrical Impedance Analysis for Estimation of Appendicular Skeletal Muscle Mass and Establishing a Cutoff for Sarcopenia. Int J Environ Res Public Health. 2017 Jul 19;14(7):809. doi: 10.3390/ijerph14070809.
• Choi SS, Lee JH, Kim D, Kim HK, Lee S, Song KJ, Park JK, Shim JH. Effectiveness and Factors Associated with Epidural Decompression and Adhesiolysis Using a Balloon-Inflatable Catheter in Chronic Lumbar Spinal Stenosis: 1-Year Follow-Up. Pain Med. 2016 Mar;17(3):476-487. doi: 10.1093/pm/pnv018. Epub 2015 Dec 7.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Sarcopenia; Frailty; Lumbar spinal stenosis; Neurogenic claudication; Neuroplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Muscular Atrophy; Atrophy; Intermittent Claudication; Sarcopenia; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: S2020-0855-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No